Working on a Human Subjects Study Record in Our Human Subjects System? ACTION NEEDED: Re-Save the Record Before Submission

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You have probably seen some of our notices and other communications regarding our transition to an updated set of grant application forms we refer to as FORMS-G (see previous Nexus post Goodbye FORMS-F, Hello FORMS-G), but there are some special considerations for those of you who had Work in Progress human subjects study records at the time of the transition.

On Thursday, February 10, 2022, eRA released a new version of Human Subjects System (HSS), to align with FORMS-G. It included a format change to accommodate updated Country codes in the PHS Human Subject Clinical Trial Information form.  We want to let you know about some steps you should take before submitting Work in Progress study records that include the PHS Human Subject Clinical Trial Information form.

Prior to submission of your application or Research Performance Progress Report (RPPR), you should re-save study records in Work in Progress applications even if you are not making changes to the study record. The Save operation updates the underlying data to match that required by the new FORMS-G. For specific instructions on saving Study Records, see FORMS-G Changes to be Reflected in Human Subjects Clinical Trials Form on February 10 – Action Required by Users.